FDA issues draft guidance on prescription drug-use related software

Sept. 22, 2023

On Sept 18, the FDA issued a draft guidance entitled, “Regulatory Considerations for Prescription Drug Use-Related Software.” Digital health technologies used with prescription drugs can potentially offer new ways to help treat patients. Software, including those designed for mobile apps, are used for health-related purposes, such as assisting patients with tracking their own drug ingestion, allowing health care practitioners to monitor patients taking a prescription drug, or providing information on how to use a drug.

Digital health technologies, like prescription drug-use-related software, may provide insight to patients, caregivers, and health care providers (collectively known as “end-users”) about a patient’s drug use. In response to comments received from the FDA’s November 2018 proposed framework “Prescription Drug-Use-Related Software,” the agency is issuing the draft guidance to clarify how the FDA will apply its drug labeling authorities to end-user output of prescription drug-use related software, how the FDA-required labeling will describe certain prescription drug-use-related software, and when and how to submit end-user output to the FDA.

To learn more, please read the CDER Conversation on software associated with prescription drug use.

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